FDA Action Update: Designations (19th September 2024)
Glycomine received FTD for GLM101
Glycomine, Inc. has received FDA Fast Track Designation for GLM101, a mannose-1-phosphate replacement therapy aimed at treating phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG). The designation underscores GLM101’s potential to address the significant unmet medical needs of PMM2-CDG patients. The Phase 2 clinical study of GLM101, involving 15 patients, has shown promising results with the drug being well-tolerated and exhibiting clinical benefit. The Fast Track program will provide Glycomine with opportunities for more frequent FDA interactions and potential accelerated approval. GLM101, also received Orphan Drug and Rare Pediatric Disease Designations, designed to bypass the deficient PMM2 enzyme and restore essential cellular functions.
Azitra received FTD for ATR-04
Azitra, Inc. has received FDA Fast Track Designation for ATR-04, a topical treatment aimed at moderate to severe skin toxicity associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). This designation highlights the FDA’s recognition of the significant unmet need for effective management of EGFRi-induced skin rashes, which can severely impact cancer patients’ quality of life. ATR-04 is a live biotherapeutic product containing a modified Staphylococcus epidermidis strain, designed to address skin toxicity caused by EGFRi therapy. Azitra plans to start a Phase 1/2 clinical trial by the end of 2024, and the Fast Track status may accelerate the development and review of ATR-04.
ImCheck Therapeutics received FTD for ICT-01
ImCheck Therapeutics has received FDA Fast Track Designation for ICT01, a humanized anti-butyrophilin 3A monoclonal antibody, in combination with azacitidine and venetoclax, aimed at treating acute myeloid leukemia (AML) in patients aged 75 or older, or those who cannot tolerate standard chemotherapy. The designation highlights the promising data from the ongoing Phase 1/2a EVICTION study, which is exploring ICT01’s effectiveness in both monotherapy and combination therapy for relapsed/refractory hematological malignancies and newly diagnosed AML patients unfit for intensive chemotherapy. The Fast Track status will facilitate more frequent FDA interactions and may lead to accelerated approval, potentially speeding up the availability of this promising treatment for AML patients.
